The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Worthington Hdl Precipitating Reagent Set.
| Device ID | K861926 |
| 510k Number | K861926 |
| Device Name: | WORTHINGTON HDL PRECIPITATING REAGENT SET |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Brewster, Phd |
| Correspondent | Brewster, Phd COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-19 |
| Decision Date | 1986-06-27 |